Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

NCT01372839 | Unknown Phase 4

• 1 other identifier: xj050511
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

Conditions

Myocardial Infarction; Unstable Angina

Keywords

Myocardial Infarction; Unstable Angina

Outcome Measures

Primary Outcomes (1)

• 30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI

  30-day

Secondary Outcomes (6)

• Post-procedural change of inflammatory biomarkers (hs-CRP)

  24h

• Morbidity of CIN

  48h

• Elevation of ALT, AST and CK

  6 months

• Number of Participants with Adverse Events

  6 months

• Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events

  6 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Drug: Atorvastatin

Usual care

OTHER

statin dose should not be higher than that described in exclusion criteria.

Drug: Statin

Interventions

Atorvastatin DRUG

Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Atorvastatin

Statin DRUG

Usual care, but statin dose should not be higher than that described in exclusion criteria

Usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Patients with clinical diagnosis of ACS
• Evidence of a personally signed and dated informed consent document

You may not qualify if:

• Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
• LDL-C \< 1.8mmol/L in patients without statin therapy in 1 months
• Endstage congestive heart failure, or LVEF \< 30%
• Active hepatic disease or hepatic dysfunction, or AST/ALT \> 1.5UNL
• Myopathy or increased creatine kinase (CK\>2 UNL)
• Severe renal dysfunction(Scr \> 3 mg/dl or 264μmol/L)
• Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
• Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
• Pregnancy, lactation, or child bearing potential women without any effective contraception
• Accompanied with malignant disease or other disease, which cause life expectancy \< 6 months
• Participating in other interventional clinical trails using drugs or devices
• Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Angina, Unstable

Interventions

Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Yong Huo, MD

  Division of Cardiology, Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Ling Tao, M.D Ph.D

CONTACT

+86-15002955798; lingtao2006@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 10, 2011
• First Posted: June 14, 2011
• Study Start: July 1, 2010
• Primary Completion: July 1, 2012
• Last Updated: June 14, 2011

Record last verified: 2010-07

Locations

CN (1)